Anxiety DisordersPhase 4NCT00044642
Lorazepam-Induced Toxicity in the Aged
A Phase 4 study testing Lorazepam in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Nathan Kline Institute for Psychiatric Research at 2 sites in United States.
Trial summary
This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder
- What is being tested?
- Lorazepam
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2000to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lorazepam treatment for at least 3 months
- Cognitively intact
- Note: Individuals who are unable or unwilling to have an MRI may be included
Who cannot join
- Major psychiatric disorder other than GAD
- Significant medical illness which may increase the likelihood of adverse reactions to lorazepam
- Severe loss of hearing or vision
- Current or past history of alcohol dependence
- Substance abuse within the past 6 months
- MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease
- Clinical symptoms that suggest neurological disease
- Dementia or other mental syndromes or disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU/Bellevue General Clinical Research Center (8East)
New York, New York, 10016
Nathan S. Kline Institute
Orangeburg, New York, 10962
About this study
Official title: Long-Term Lorazepam Use and Acute Toxicity in the Aged
This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).
Read the detailed description
GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls.
Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Being tested
- Lorazepam
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startDec 2000
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Nunzio Pomara, MD, Principal investigator, Nathan S. Kline Institute and New York University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044642
- Sponsor's protocol ID
- R01MH059142
- Other IDs
- R01MH059142, DATR A4-GPX
- Status last verified
- Dec 2013
- First submitted
- 3 Sep 2002
- Last updated
- 6 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Lorazepam Use and Acute Toxicity in the Aged
- ClinicalTrials.gov ID
- NCT00044642
- Acronym / sponsor ID
- R01MH059142
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Keywords
- Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2000
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).
Detailed description
GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls.
Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lorazepam treatment for at least 3 months
- Cognitively intact
- Note: Individuals who are unable or unwilling to have an MRI may be included
Key exclusion criteria (8 listed)
- Major psychiatric disorder other than GAD
- Significant medical illness which may increase the likelihood of adverse reactions to lorazepam
- Severe loss of hearing or vision
- Current or past history of alcohol dependence
- Substance abuse within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorazepam | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nunzio Pomara, MD principal investigator
Nathan S. Kline Institute and New York University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorazepam in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Nathan Kline Institute for Psychiatric Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.